Luis Nieves

Luis Nieves is a seasoned Senior Auditor with 38 years of experience in the pharmaceutical and biotech industry. Luis has honed his expertise in navigating the intricate landscape of FDA and global requirements, ensuring precision in regulatory compliance and quality standards. His extensive experience encompasses cGMP Certification Audits, cGMP Self Inspection Audits, Prior Approval Inspection Readiness Assessments, Supplier Audits, and Due Diligence Assessments.

Luis possesses a distinctive talent and demeanor, enabling him to collaborate effectively with clients, balancing customer processes and products while achieving compliance. He excels at identifying quality and compliance issues to minimize risk for our valued customers. Additionally, Luis has the invaluable qualification of speaking both English and Spanish fluently.